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PE20131101A1 - STORAGE STABLE FORMULATIONS OF OXYCODONE AND NALOXONE - Google Patents

STORAGE STABLE FORMULATIONS OF OXYCODONE AND NALOXONE

Info

Publication number
PE20131101A1
PE20131101A1 PE2013000252A PE2013000252A PE20131101A1 PE 20131101 A1 PE20131101 A1 PE 20131101A1 PE 2013000252 A PE2013000252 A PE 2013000252A PE 2013000252 A PE2013000252 A PE 2013000252A PE 20131101 A1 PE20131101 A1 PE 20131101A1
Authority
PE
Peru
Prior art keywords
oxycodone
naloxone
storage stable
stable formulations
povidone
Prior art date
Application number
PE2013000252A
Other languages
Spanish (es)
Inventor
Derek Allan Prater
Christof Spitzley
Gerhard Josef Heun
Udo Hahn
Christian Leuner
Alexander Schutz
Original Assignee
Euro Celtique Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43382375&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20131101(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of PE20131101A1 publication Critical patent/PE20131101A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Zoology (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

REFERIDA A UNA COMPOSICION FARMACEUTICA ORAL DE LIBERACION PROLONGADA QUE COMPRENDE: a) UN MATERIAL DE LIBERACION PROLONGADA TAL COMO UN ETER DE CELULOSA, UN COPOLIMERO DE BASE METACRILICA Y/O UN ALCOHOL GRASO Y b) OXICODONA Y NALOXONA O UNA SAL DE LOS MISMOS EN UNA RELACION DE 2:1 EN PESO. TAMBIEN COMPRENDE UN MATERIAL DE RELLENO TAL COMO LACTOSA MONOHIDRATO, UN LUBRICANTE TAL COMO ESTEARATO DE MAGNESIO Y/O TALCO Y UN AGLUTINANTE TAL COMO HIDROXIPROPILCELULOSA, POVIDONA, CO-POVIDONA, ALMIDON, ENTRE OTROS. DICHA COMPOSICION ES ESTABLE EN ALMACENAMIENTO DURANTE PERIODOS PROLONGADOS DE TIEMPOREFERRING TO AN ORAL PHARMACEUTICAL COMPOSITION OF PROLONGED RELEASE THAT INCLUDES: a) A MATERIAL OF PROLONGED RELEASE SUCH AS A CELLULOSE ETHER, A METHACRYLIC-BASED COPOLYMER AND / OR A FATTY ALCOHOL AND b) OXYCODONE AND NALOXONE SALT A RATIO OF 2: 1 IN WEIGHT. IT ALSO INCLUDES A FILLING MATERIAL SUCH AS LACTOSE MONOHYDRATE, A LUBRICANT SUCH AS MAGNESIUM STEARATE AND / OR TALC, AND A BINDER SUCH AS HYDROXYPROPYL CELLULOSE, POVIDONE, CO-POVIDONE, STARCH, AMONG OTHERS. SUCH COMPOSITION IS STABLE IN STORAGE FOR LONG PERIODS OF TIME

PE2013000252A 2010-08-13 2011-08-11 STORAGE STABLE FORMULATIONS OF OXYCODONE AND NALOXONE PE20131101A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37334410P 2010-08-13 2010-08-13
EP10172759 2010-08-13

Publications (1)

Publication Number Publication Date
PE20131101A1 true PE20131101A1 (en) 2013-09-23

Family

ID=43382375

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2013000252A PE20131101A1 (en) 2010-08-13 2011-08-11 STORAGE STABLE FORMULATIONS OF OXYCODONE AND NALOXONE

Country Status (29)

Country Link
US (2) US20130245054A1 (en)
EP (2) EP3505162A1 (en)
JP (1) JP6007176B2 (en)
KR (1) KR101518143B1 (en)
CN (1) CN103118668B (en)
AR (1) AR082688A1 (en)
AU (1) AU2011288413B2 (en)
BR (1) BR112013003150B1 (en)
CA (1) CA2805974C (en)
CH (1) CH705678B1 (en)
CL (1) CL2013000444A1 (en)
CO (1) CO6680640A2 (en)
DE (1) DE112011102708T5 (en)
DK (1) DK178702B1 (en)
EC (1) ECSP13012467A (en)
ES (1) ES2409069B2 (en)
GB (1) GB2495676B (en)
MX (1) MX355644B (en)
MY (1) MY165149A (en)
NO (1) NO20130366A1 (en)
NZ (1) NZ606123A (en)
PE (1) PE20131101A1 (en)
PH (1) PH12013500172A1 (en)
RU (1) RU2572695C2 (en)
SE (1) SE537698C2 (en)
SG (1) SG187678A1 (en)
SI (1) SI2603205T1 (en)
TW (1) TWI469781B (en)
WO (1) WO2012020097A2 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
EP1685839B8 (en) 1997-12-22 2013-06-26 Euro-Celtique S.A. Pharmaceutical oral dosage form comprising a combination of an opioid agonist and opioid antagonist
CA2446550C (en) 2001-05-11 2012-03-06 Endo Pharmaceuticals, Inc. Abuse-resistant controlled-release opioid dosage form
ES2627298T3 (en) 2002-04-05 2017-07-27 Mundipharma Pharmaceuticals S.L. Pharmaceutical preparation containing oxycodone and naloxone
EP1702558A1 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
RS58240B1 (en) 2009-03-10 2019-03-29 Euro Celtique Sa Immediate release pharmaceutical compositions comprising oxycodone and naloxone
US9993433B2 (en) 2010-05-10 2018-06-12 Euro-Celtique S.A. Manufacturing of active-free granules and tablets comprising the same
MX344846B (en) 2010-05-10 2017-01-10 Euro-Celtique S A * COMBINATION OF ACTIVE LOADED GRANULES WITH ADDITIONAL ASSETS.
US20140271893A1 (en) * 2013-03-15 2014-09-18 Mcneil-Ppc, Inc. Coated phenylephrine particles and use thereof in pharmaceutical formulations
WO2015011189A1 (en) 2013-07-23 2015-01-29 Euro-Celtique S.A. A combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation
JP6539274B2 (en) 2013-08-12 2019-07-03 ファーマシューティカル マニュファクチュアリング リサーチ サービシズ,インコーポレーテッド Extruded immediate release abuse deterrent pills
EP3068397A1 (en) 2013-11-13 2016-09-21 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2016010771A1 (en) 2014-07-17 2016-01-21 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
JP2017531026A (en) 2014-10-20 2017-10-19 ファーマシューティカル マニュファクチュアリング リサーチ サービシズ,インコーポレーテッド Sustained release abuse deterrent liquid filler form
WO2016091805A2 (en) * 2014-12-08 2016-06-16 Develco Pharma Schweiz Ag Naloxone monopreparation and multi-layer tablet
US20180104236A1 (en) 2016-09-26 2018-04-19 Euro-Celtique S. A. Methods of treatment comprising administering a high daily dose of oxycodone and naloxone in a 2:1 weight ratio
WO2018189311A1 (en) * 2017-04-13 2018-10-18 Jean Paul Remon Xanthohumol-based compositions
CN111686094A (en) * 2020-07-13 2020-09-22 云南民族大学 Application of fatty alcohol compound in preparation of laxative

Family Cites Families (17)

* Cited by examiner, † Cited by third party
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EP0164669B1 (en) 1984-06-13 1991-01-23 Röhm Gmbh Process for coating pharmaceutical forms
HU218673B (en) * 1993-10-07 2000-10-28 Euroceltique S.A. An extended release oral pharmaceutical composition and method comprising an opioid analgesic
US6245357B1 (en) * 1998-03-06 2001-06-12 Alza Corporation Extended release dosage form
JP4848558B2 (en) * 2001-05-08 2011-12-28 トーアエイヨー株式会社 Rapid-release tablets containing metformin hydrochloride
JP4256259B2 (en) * 2001-07-18 2009-04-22 ユーロ−セルティーク エス.エイ. Pharmaceutical formulation of oxycodone and naloxone
US7332182B2 (en) * 2001-08-06 2008-02-19 Purdue Pharma L.P. Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant
JP2003160487A (en) * 2001-11-20 2003-06-03 Ohara Yakuhin Kogyo Kk Pravastatin sodium-containing tablet and method for producing the same
ES2627298T3 (en) * 2002-04-05 2017-07-27 Mundipharma Pharmaceuticals S.L. Pharmaceutical preparation containing oxycodone and naloxone
US20060009478A1 (en) * 2003-10-15 2006-01-12 Nadav Friedmann Methods for the treatment of back pain
EP1604666A1 (en) * 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD)
EP1604667A1 (en) * 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioids for the treatment of the restless leg syndrome
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Also Published As

Publication number Publication date
EP3505162A1 (en) 2019-07-03
JP2013533303A (en) 2013-08-22
US20160095853A1 (en) 2016-04-07
CH705678B1 (en) 2016-03-15
GB2495676A (en) 2013-04-17
GB2495676B (en) 2018-08-22
TWI469781B (en) 2015-01-21
ES2409069B2 (en) 2014-07-17
RU2572695C2 (en) 2016-01-20
ES2409069R1 (en) 2013-08-30
TW201228662A (en) 2012-07-16
SG187678A1 (en) 2013-03-28
AU2011288413A1 (en) 2013-02-21
SE537698C2 (en) 2015-09-29
DK178702B1 (en) 2016-11-21
CN103118668B (en) 2016-07-06
MX2013001757A (en) 2013-05-06
WO2012020097A2 (en) 2012-02-16
PH12013500172A1 (en) 2022-10-24
EP2603205A2 (en) 2013-06-19
CN103118668A (en) 2013-05-22
NZ606123A (en) 2015-03-27
GB201301916D0 (en) 2013-03-20
DE112011102708T5 (en) 2013-05-29
AR082688A1 (en) 2012-12-26
KR20130083903A (en) 2013-07-23
MY165149A (en) 2018-02-28
CA2805974C (en) 2019-11-26
ECSP13012467A (en) 2013-03-28
KR101518143B1 (en) 2015-05-06
CO6680640A2 (en) 2013-05-31
NO20130366A1 (en) 2013-04-29
BR112013003150A2 (en) 2020-09-08
BR112013003150B1 (en) 2022-01-18
JP6007176B2 (en) 2016-10-12
SE1350286A1 (en) 2013-03-21
RU2013110820A (en) 2014-09-20
WO2012020097A3 (en) 2012-05-03
MX355644B (en) 2018-04-26
EP2603205B1 (en) 2018-10-03
AU2011288413B2 (en) 2014-05-22
CA2805974A1 (en) 2012-02-16
CL2013000444A1 (en) 2013-08-23
ES2409069A2 (en) 2013-06-24
DK201370075A (en) 2013-02-13
US20130245054A1 (en) 2013-09-19
SI2603205T1 (en) 2019-02-28

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